ID

35083

Beschrijving

Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention; ODM derived from: https://clinicaltrials.gov/show/NCT02035631

Link

https://clinicaltrials.gov/show/NCT02035631

Trefwoorden

  1. 14-02-19 14-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 februari 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Neoplasms NCT02035631

Eligibility Breast Neoplasms NCT02035631

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
incident primary breast cancer (icd-o c50)
Beschrijving

Breast Carcinoma Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
stage at diagnosis i, ii, iiia (or t1-3, n0-n2, m0)
Beschrijving

TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1]
C0474926
age at diagnosis below 76 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
within 3 months since completion of standard treatment (excluding hormonal therapy) and within 15 months since the diagnosis of the disease
Beschrijving

Standard therapy Completion | Hormone Therapy Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0332196
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
morbid obesity (bmi >40kg/m²) or underweight (bmi <18kg/m²)
Beschrijving

Obesity, Morbid | Body mass index | Underweight

Datatype

boolean

Alias
UMLS CUI [1]
C0028756
UMLS CUI [2]
C1305855
UMLS CUI [3]
C0041667
ischemic heart disease (coronary syndrome, unstable angina or myocardial infarction) or cerebrovascular incident (ischemic or hemorrhagic) during the previous 12 months
Beschrijving

Myocardial Ischemia | Acute Coronary Syndrome | Angina, Unstable | Myocardial Infarction | Cerebrovascular accident Ischemic | Cerebrovascular accident Hemorrhagic

Datatype

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0948089
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0038454
UMLS CUI [5,2]
C0475224
UMLS CUI [6,1]
C0038454
UMLS CUI [6,2]
C0333275
diabetes (only if unstable - glycosylated haemoglobin >9%)
Beschrijving

Diabetes Mellitus | Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0202054
current medical or surgical treatment to lose weight
Beschrijving

Weight reduction regimen | Bariatric Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0311130
UMLS CUI [2]
C1456587
mental illness that would prevent the patient from carrying out the intervention
Beschrijving

Mental disorders Preventing Intervention

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0184661
logistical factors which would prevent the patient from carrying out the intervention (distance to travel, work or family commitments)
Beschrijving

Logistics Factor Preventing Intervention

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242415
UMLS CUI [1,2]
C1521761
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0184661
pregnant or planning pregnancy
Beschrijving

Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992

Similar models

Eligibility Breast Neoplasms NCT02035631

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Primary
Item
incident primary breast cancer (icd-o c50)
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
TNM Breast tumor staging
Item
stage at diagnosis i, ii, iiia (or t1-3, n0-n2, m0)
boolean
C0474926 (UMLS CUI [1])
Age
Item
age at diagnosis below 76 years
boolean
C0001779 (UMLS CUI [1])
Standard therapy Completion | Hormone Therapy Excluded
Item
within 3 months since completion of standard treatment (excluding hormonal therapy) and within 15 months since the diagnosis of the disease
boolean
C2936643 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Obesity, Morbid | Body mass index | Underweight
Item
morbid obesity (bmi >40kg/m²) or underweight (bmi <18kg/m²)
boolean
C0028756 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
C0041667 (UMLS CUI [3])
Myocardial Ischemia | Acute Coronary Syndrome | Angina, Unstable | Myocardial Infarction | Cerebrovascular accident Ischemic | Cerebrovascular accident Hemorrhagic
Item
ischemic heart disease (coronary syndrome, unstable angina or myocardial infarction) or cerebrovascular incident (ischemic or hemorrhagic) during the previous 12 months
boolean
C0151744 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0038454 (UMLS CUI [5,1])
C0475224 (UMLS CUI [5,2])
C0038454 (UMLS CUI [6,1])
C0333275 (UMLS CUI [6,2])
Diabetes Mellitus | Glucohemoglobin measurement
Item
diabetes (only if unstable - glycosylated haemoglobin >9%)
boolean
C0011849 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
Weight reduction regimen | Bariatric Surgery
Item
current medical or surgical treatment to lose weight
boolean
C0311130 (UMLS CUI [1])
C1456587 (UMLS CUI [2])
Mental disorders Preventing Intervention
Item
mental illness that would prevent the patient from carrying out the intervention
boolean
C0004936 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Logistics Factor Preventing Intervention
Item
logistical factors which would prevent the patient from carrying out the intervention (distance to travel, work or family commitments)
boolean
C0242415 (UMLS CUI [1,1])
C1521761 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
Pregnancy | Pregnancy, Planned
Item
pregnant or planning pregnancy
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])

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